NEWS RELEASE / REGULATED INFORMATION / INSIDE INFORMATION
IRVINE, CA, and HERSTAL, BELGIUM – 07:00 CEST, June 28 2017 – MDxHealth SA (Euronext: MDXH.BR) today announced its activities at the fifth Global Congress on Prostate Cancer in Lisbon, Portugal (June 28-30) with presentation of three SelectMDx® studies and inclusion in a keynote address.
On Wednesday June 28 at 13.50 WEST, Prof. Nicolaas Lumen, MD, Clinical Head of Urology at University Hospital in Ghent, Belgium will give a keynote lecture entitled “Biomarkers in 2017.” Lumen’s talk will include an overview of biomarkers for prostate cancer diagnosis and polled physician perceptions of their use. Additionally, Prof. Lumen announced that he will discuss the latest developments in biomarker-based tests, such as SelectMDx, and their implementation in daily clinical practice. The presentation will be recorded and will be available on www.ProstateMDx.org the following week.
Following the keynote lecture, three studies on SelectMDx will be presented as posters:
Results from a new clinical utility study showed that compared to the European Randomized Study of Screening for Prostate Cancer (ERSPC) risk calculator (RC) the use of SelectMDx led to a reduction of biopsies in men at risk for prostate cancer and improved the detection of significant prostate cancer in men with prior negative biopsies.
Data demonstrating that SelectMDx predicted magnetic resonance imaging (MRI) outcomes previously presented at the American Urological Association (AUA) Annual Meeting will be re-presented.
Thursday, 29 June at 13:15 WEST: Analytical validation of an mRNA-based urine test to predict the presence of high-grade prostate cancer
A previously published study for SelectMDx that demonstrated consistent test performance between laboratories, will be presented as a poster for the first time. This data will be of interest to laboratories and hospitals looking to perform the SelectMDx test in their own facilities using an in vitro diagnostic (IVD) PCR kit that launched earlier this month.
Of the more than 2 million prostate biopsies performed each year in the US and Europe, less than a third find cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive ‘liquid biopsy’ method to assess a man’s risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce diagnostic procedures, such as MRI and invasive prostate biopsies, by approximately 50%, thereby reducing healthcare costs.
MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company’s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
For more information:
Shalon Roth, EVP Corporate Communications
+44 (0)7393 906278
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
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